Page 16 - The Care and Handling of Flexible Scopes v3

Care of Flexible Endoscopes

13. Sterilisation and High-Level Disinfection

In 1968, Dr. Earle Spaulding developed a classification system for cleaning and
reprocessing instruments and equipment according to the level of infection risk
associated with their intended use. He divided the risk level into three categories, all
related to body contact: critical (entry or penetration into sterile tissue, cavity or
bloodstream), semi-critical (contact with intact non-sterile mucosa or non-intact skin)
and noncritical (intact skin).

Instruments defined as critical should always be sterilised before use. Instruments
considered semi-critical should be at least high-level disinfected (HLD) or, ideally,
sterilised. Instruments classified as noncritical should be washed and treated with a low-
level disinfectant or detergent and water (see Table 1).

Table 1 – Spaulding Classification System

Spaulding Classification System

Body Contact Level of Risk Disinfection Requirements
Entry or penetration into sterile Critical Sterilisation
tissue, cavity or bloodstream
Intact non-sterile mucosa or Semi-critical Sterilisation or HLD
non-intact skin
Intact skin Non-critical Low-level

Always check manufacturer’s instructions for material compatibility and sterility efficacy for
endoscopes and instruments. Facilities also should refer to the Spaulding Classification
when choosing the reprocessing method most appropriate to the risk of infection related to
the use of endoscopes and instruments.

Use an open tray, rigid container, or Tyvek pouch suitable for terminal sterilisation,
including sterility assurance indicators, to package the instrument. Wrap in a tray using
sterilisation wrap or containerise into a rigid container (see Figures 9 and 10).

Figure 9 – Rigid Endoscope Ready for Final Packaging and Sterilisation

Page | 16 Avensys UK Ltd